Tirzepatide + Exercise for Obesity

(EXER-MED Trial)

DL
Overseen ByDamon L Swift, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Virginia
Must be taking: Weight loss medication
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity.

The main questions it will answer includes:

* Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone

* Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life

Participants will:

* Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician

* (Exercise group only) Will perform exercise \~3 times a week at the University of Virginia). Walking on a treadmill and resistance training

* Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures

Who Is on the Research Team?

DL

Damon L Swift, Ph.D

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

Adults aged 30-65 with obesity or overweight and additional heart-related risk factors can join this trial. They must be healthy enough for weight loss medication, willing to consent, and have their doctor's approval.

Inclusion Criteria

I am willing and healthy enough to start a weight loss medication.
I am willing and able to sign a consent form.
My doctor agrees I can start weight loss medication.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide monthly and engage in exercise (for the exercise group) for 16 weeks

16 weeks
2 visits (in-person) at the beginning and end of the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Exercise
  • Tirzepatide

Trial Overview

The study tests if exercise combined with the weight loss drug Tirzepatide is more effective than the drug alone in reducing body weight/fat and improving blood sugar, cholesterol levels, fitness, and quality of life.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment2 Interventions
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+